Plain English Summary
Background and study aims
An increased intensity of physiotherapy, including an individualised structured exercise programme, may be beneficial for critically ill patients. The aim of this study is to compare two intensities of physiotherapy in critically ill patients.
Who can participate?
Critically ill surgical or medical patients, over 18 years of age, who have been ventilated for between 48 and 72 hours
What does the study involve?
Participants are randomly allocated to one of two groups. Group 1 (control group) receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session. Group 2 (intervention group) receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme. Physical quality of life is compared on Critical Care discharge and 3 and 6 months later. Changes in participants' mental health and the economic costs of the interventions are also assessed.
What are the possible benefits and risks of participating?
The possible benefits of participating are that if additional physiotherapy is shown to be beneficial to Critical Care patients, research participants will also benefit. This could be shown as improvements to physical function, longer-term health, exercise capacity and overall quality of life. During physiotherapy sessions, research participants will be monitored closely, and if any specific events occur, the session will be stopped. Research participants are patients who are already critically ill, and so additional precautions will be taken to ensure that the risks of participating are minimised.
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2012 to June 2015
Who is funding the study?
National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB)
Who is the main contact?
Miss Gillian Watson
gillian.watson@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Gillian Watson
ORCID ID
Contact details
Newcastle Clinical Trials Unit
Institute of Health & Society
Newcastle University
4th Floor
William Leech Building
Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 8813
gillian.watson@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11389
Study information
Scientific title
A randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill: Extra Physiotherapy In Critical Care
Acronym
EPICC
Study hypothesis
This study aims to compare two intensities of physiotherapy in critically ill patients. The trialists believe that an increased intensity of physiotherapy, including an individualised structured exercise programme, will be beneficial for critically ill patients. To assess this, their physical quality of life will be compared on Critical Care discharge, and at 3 and 6 months following initial recruitment to the study. Changes in participants' mental health and the economic costs of the interventions will also be assessed.
Ethics approval
South Central - Southampton B Research Ethics Committee, first MREC approval date 20/07/2011, ref: 11/NE/0206
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact gillian.watson@ncl.ac.uk to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care
Intervention
Group 1 (control group) will receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session.
Group 2 (intervention group) will receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Physical QoL; Timepoint(s): 6 months
Secondary outcome measures
1. Changes in mental health; Timepoint(s): 6 months
2. Economic costs of intervention; Timepoint(s): 6 months
Overall trial start date
16/01/2012
Overall trial end date
04/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant has provided written informed consent, or their Personal Consultee has provided a signed Personal Consultee Declaration Form, for participation in the study, prior to any study specific procedures taking place
2. Medical and surgical patients (surgical patients are those admitted to ICU as a direct consequence of an operative procedure, or as a consequence of that procedure. All other patients are termed medical)
3. Age 18 years or over
4. Invasive or noninvasive ventilation for more than 48 hours
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 308; UK Sample Size: 308
Participant exclusion criteria
1. Invasive or non-invasive ventilation for more than 72 hours
2. Under 18 years
3. Patients receiving end-of-life care
4. Patients not expected to survive for more than 48 hours after enrolment
5. Acute brain injury
6. Acute spinal cord injury
7. Spinal surgery
8. Brain surgery
9. Multiple trauma
10. Burns
11. Rapidly progressive neuromuscular disease
12. Enrolment in another clinical trial
13. Post-cardiac arrest
Recruitment start date
16/01/2012
Recruitment end date
04/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26009576
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28780504